3D Medicines Inc. (01244) announced that key results from its national Phase III pivotal trial evaluating Envafolimab Injection combined with gemcitabine and oxaliplatin (GEMOX) as first-line therapy for advanced biliary tract cancer (BTC) have been selected for official presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

Envafolimab, co-developed with Alphamab Oncology, is the world’s first commercially launched subcutaneous PD-L1 inhibitor and first single-domain antibody for tumor treatment. The drug has been approved and marketed in China for four years, achieving cumulative domestic sales exceeding RMB2.00 billion.

Study design and significance • Prospective, randomized, active-controlled, open-label, multi-center Phase III trial in Chinese patients with advanced BTC. • Comparison: Envafolimab + GEMOX versus GEMOX alone. • Outcome: The regimen delivered favorable survival benefits, supplying high-level evidence for China’s clinical practice guidelines and expanding immune-combination strategies for BTC.

Presentation details • Abstract No.: 4118 • Session: Gastrointestinal, Pancreatic and Hepatobiliary Cancer • Poster Board: 101 • Time: 9:00 AM – 12:00 PM CDT, 30 May 2026

Additional developments Three other clinical studies from 3D Medicines have also been accepted by ASCO 2026. The company is negotiating Envafolimab licensing rights in the United States, Japan and Europe, aiming to broaden the drug’s geographic reach.

Regulatory path New indication approval remains subject to further data verification and regulatory review. The company advises shareholders and potential investors to exercise caution when making investment decisions.